Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients

Recruiting Phase 3 Interventional Study
Kidney Transplant Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
144 (estimated)
Sponsor
University Hospital, Rouen · Other
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About This Trial
Cytomegalovirus (CMV) establishes a chronic infection in 60% of the general population. In renal transplant recipients, it is responsible for morbidities occurring mainly in the first 6 months after transplantation. These include viral reactivations linked to immunosuppressive treatment inhibiting the anti-CMV T lymphocyte response. CMV infection, a sign of uncontrolled viral replication, is defin…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Renal transplant patient for 1 to 12 days * CMV seropositivity on the day of transplantation: IgG threshold =6 AU/mL CMIA CMV IgG, Architect i4000 (Abbott)) (Serology performed on D0, before the transplant) * Non-depleting inducing immunosuppressive treatment (Basiliximab) (im…
Contacts

Dominique Bertrand

0232885452

dominique.bertrand@chu-rouen.fr

CONTACT